GlideRite® Rigid Stylet Versus Parker Flex-It Stylet

NCT02439606 | Completed

• 1 other identifier: E-14-1074
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients undergoing elective non-cardiac surgery that required general anesthesia with orotracheal intubation.

Conditions

Anesthesia

Keywords

GlideRite; Stylet; Parker; orotracheal; intubation; GlideScope

Outcome Measures

Primary Outcomes (1)

• total intubation time

  the time from insertion of the blade of the GlideScope into the oral airway to the appearance of end-tidal carbon dioxide (ETCO2) curve of at least 30 mmHg on the anesthesia monitor after insertion of the tracheal tube.

  measured during intubation ( up to 120 seconds)

Secondary Outcomes (1)

• number of intubation attempts before successful intubation

  5minutes

Study Arms (2)

Glide Rite Rigid Stylet group

ACTIVE COMPARATOR

Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.

Device: Glide Rite Rigid Stylet group

Parker-Flex-It Directional Stylet group

EXPERIMENTAL

Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It Directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.

Device: Parker Flex-It directional stylet group

Interventions

Glide Rite Rigid Stylet group DEVICE

Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.

Glide Rite Rigid Stylet group

Parker Flex-It directional stylet group DEVICE

Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.

Parker-Flex-It Directional Stylet group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I\&II,
• body mass index (BMI) \< 35
• elective non-cardiac surgery
• general anaesthesia with orotracheal intubation

You may not qualify if:

• Anticipated difficult airway,
• need for rapid sequence induction,
• ASA physical status III-V,
• increase risk of gastric aspiration such as gastro- oesophageal reflux,
• pregnancy,
• patients who had no teeth, loose teeth or oral trauma, known pathology or previous surgery to the mouth, pharynx, larynx or cervical spine and any reason why the GlideScope is not, or could not be used.

Sponsors & Collaborators

• King Saud University: lead

Study Officials

• Ashraf Abdelhalim, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Anesthesia

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05